510(k) K022256

SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN by Tucker & Associates — Product Code FXX

K022256 is an FDA 510(k) premarket notification submitted by Tucker & Associates for the device "SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN". The FDA issued a decision of Substantially Equivalent on April 26, 2004. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Tucker & Associates has at least 3 other 510(k) clearances on record.